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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00196794




Registration number
NCT00196794
Ethics application status
Date submitted
13/09/2005
Date registered
20/09/2005
Date last updated
19/03/2014

Titles & IDs
Public title
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Scientific title
A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Secondary ID [1] 0 0
GD3-170-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clostridium Enterocolitis 0 0
Diarrhea 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tolevamer potassium-sodium (GT267-004)

Treatment: Drugs: Tolevamer potassium-sodium (GT267-004)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Resolution of diarrhea
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time to resolution of diarrhea
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Recurrence rate
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Number of stools
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Average stool consistency
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Treatment success
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- 18 years of age and above

- The presence of CDAD at the time of enrollment with no other likely etiology for the
diarrhea

- Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other
antibacterial therapy specific for CDAD

- Baseline serum potassium > 3.0 mmol (meq)/L

- Patient considered sufficiently stable clinically to likely complete 6 week study
period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
520
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bedford Park
Recruitment hospital [3] 0 0
- Cairns
Recruitment hospital [4] 0 0
- Concord
Recruitment hospital [5] 0 0
- Darlinghurst
Recruitment hospital [6] 0 0
- Five Dock
Recruitment hospital [7] 0 0
- Footscray
Recruitment hospital [8] 0 0
- Herston
Recruitment hospital [9] 0 0
- Hobart
Recruitment hospital [10] 0 0
- Kogarah
Recruitment hospital [11] 0 0
- Nambour
Recruitment hospital [12] 0 0
- Nedlands
Recruitment hospital [13] 0 0
- Parkville
Recruitment hospital [14] 0 0
- Perth
Recruitment hospital [15] 0 0
- Randwick
Recruitment hospital [16] 0 0
- South Brisbane
Recruitment hospital [17] 0 0
- Southport
Recruitment hospital [18] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
2139 - Concord
Recruitment postcode(s) [5] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [6] 0 0
2046 - Five Dock
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment postcode(s) [8] 0 0
4032 - Herston
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
2217 - Kogarah
Recruitment postcode(s) [11] 0 0
4560 - Nambour
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
3050 - Parkville
Recruitment postcode(s) [14] 0 0
6000 - Perth
Recruitment postcode(s) [15] 0 0
2031 - Randwick
Recruitment postcode(s) [16] 0 0
4101 - South Brisbane
Recruitment postcode(s) [17] 0 0
4215 - Southport
Recruitment postcode(s) [18] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Innsbruck
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Austria
State/province [3] 0 0
Oberndorf
Country [4] 0 0
Austria
State/province [4] 0 0
Salzburg
Country [5] 0 0
Belgium
State/province [5] 0 0
Aalst
Country [6] 0 0
Belgium
State/province [6] 0 0
Braine L'Alleud
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Hasselt
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Yvoir
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Brno
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Czech Republic
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Hradec Kralove
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Melnik
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Czech Republic
State/province [15] 0 0
Ostrava
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Czech Republic
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Praha
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Denmark
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Copenhagen
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Denmark
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Herlev
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Denmark
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Hvidovre
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France
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Amiens
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France
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Annecy
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France
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Clichy
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France
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Creteil
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France
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Dijon
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France
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Garches
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Nice
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State/province [27] 0 0
Paris
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France
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Saint Etienne
Country [29] 0 0
France
State/province [29] 0 0
Tourcoing
Country [30] 0 0
France
State/province [30] 0 0
Vandoeuvre-les-Nancy
Country [31] 0 0
Germany
State/province [31] 0 0
Augsburg
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Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Frankfurt
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Germany
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Greifswald
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Germany
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Hannover
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Germany
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Hofheim
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Germany
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Köln
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Germany
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Leipzig
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Germany
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Lübeck
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Germany
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Regensburg
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Germany
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Wilhelmshaven
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Ireland
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Castlebar
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Ireland
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Cork
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Ireland
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Dublin
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Norway
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Bergen
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Bodo
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Oslo
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Stavanger
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Tonsberg
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Norway
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Tromso
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Trondheim
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Portugal
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Carnaxide
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Coimbra
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Matosinhos
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Porto
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Alcala de Henares
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Badalona
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Barcelona
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Cordoba
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El Palmar-Murcia
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Guadalajara
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Leganes
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Lleida
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Madrid
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San Sebastian
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Santander
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Spain
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Sevilla
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Terrassa
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Sweden
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Goteborg
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Sweden
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Joenkoeping
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Sweden
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Kalmar
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Karlskrona
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Kristianstad
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Lund
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Malmö
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Oerebro
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Skoevde
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Switzerland
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Baden
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Basel
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Bellinzona
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Geneva
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Switzerland
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Lugano
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United Kingdom
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Abergavenny
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United Kingdom
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Birmingham
Country [86] 0 0
United Kingdom
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Bristol
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United Kingdom
State/province [87] 0 0
Bury
Country [88] 0 0
United Kingdom
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Cardiff
Country [89] 0 0
United Kingdom
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Edinburgh
Country [90] 0 0
United Kingdom
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Gwent
Country [91] 0 0
United Kingdom
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Ipswich
Country [92] 0 0
United Kingdom
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Keighley
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United Kingdom
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Leeds
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United Kingdom
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Liverpool
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United Kingdom
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London
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Salford
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Sheffield
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Stockport
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Sunderland
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Winchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Approximately 520 patients will be entered into this study taking place throughout Australia
and Europe. This study aims to determine if an investigational drug is safe and effective for
treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat
episodes of CDAD. The investigational drug will be evaluated in comparison to current
standard antibiotic treatment, so all patients will receive active medication. All study
related care is provided including doctor visits, physical exams, laboratory tests, and study
medication. The total length of participation is approximately 6 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00196794
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Genzyme, a Sanofi Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00196794